The first step in developing a sterility assurance program is to list each step in the process, beginning at the point of use and ending in sterile storage. Each step should be evaluated for ways to prevent contamination in the manufacturing process or environments. This article shares the components for a holistic sterility assurance program needed for an aseptic manufactured product.
- Medical Device Commercialization: Traits For You To Be Successful, Part 2
- Creating The Culture Of Cell Culture
- An Introduction To Biopharma Facility Design & Layout
- The Impact Of Market Restrictions On The U.S. Stem Cell Biomaterials Market
- COVID-19 Spurs Growth Of China’s Domestic Bioprocessing Suppliers
- How To Coordinate Your Site Selection With State Economic Development
- A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk
Medical Device Commercialization: Traits For You To Be Successful, Part 2
In this author's first article, he examined the first five of nine traits to “BE” as you move your medtech innovation further along the path to commercialization, growth, and profitability. This article focuses on the other four traits.
An Introduction To Biopharma Facility Design & Layout
This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.
The Impact Of Market Restrictions On The U.S. Stem Cell Biomaterials Market
Biomaterials are biomedical materials that can be safely implanted or injected into the body and are, more often than not, a form of biologically active tissue themselves. This article examines stem cell research and the market of cell-based products for orthopedic biomaterials.
COVID-19 Spurs Growth Of China’s Domestic Bioprocessing Suppliers
Just as the U.S. and European bioprocessing supply systems have seen more robust growth than ever before, China’s domestic demands for single-use bags, cell culture media, and purification resins are all on the rise. BioPlan’s Top1000Bio database of global bioprocessing facilities has tracked industry capacity and employment growth over 15 years.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk
In Part 1 of this 2-part series, the authors presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article (Part 2) provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I
This article introduces a novel model of benefit-risk by taking a bottom-up approach using the _risk of the therapy_ and comparing it to _risk of no therapy_ to quantify risk and benefit with the same scale. This overview is relevant not only to the pharmaceutical and biotech industries, but also the medical device industry.
Is A SPAC The Right Option For Your Emerging Biotech?
As biotech and emerging pharma companies weigh their options for raising capital, the popularity of the special purpose acquisition company (SPAC) has surged, with a 175% increase in announced SPAC M&As seen between 2019 and 2020. This article examines the considerations you should make when weighing if a SPAC is the right option for your company.
Forging A New Path Forward in Manufacturing Genetic Medicines
While the past decade’s focus on scientific advances has accelerated the advancement of genetic medicines, including gene and cell therapies, manufacturing is vital to product quality, safety, efficacy and clinical trial and commercial supply. In the case of adeno-associated virus (AAV)-based gene therapy and gene editing product development, manufacturing is no simple task. As the industry advances these genetic medicines, manufacturing is also ramping up, and with it optimization and efficiencies of scale. Since the industry is still maturing, and manufacturing know-how is often kept proprietary, companies must learn, adapt, and master novel innovations as well as challenges on their own.
PHARMA OUTSOURCING WHITE PAPERS
Powder-In-Capsule Micro-Dosing Accelerates Drug Development
Precision powder micro-dosing in capsules makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.
LV Scale-Up Workflow In Single-Use Bioreactors For GMP Compliance
Cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.
Understanding Perfusion Terminology
Over the past several years, perfusion has become an increasingly attractive process for development in the biopharmaceutical industry. To fully evaluate whether a perfusion application will work in a production process, it is critical to have standardized terminology. This white paper explains key terms that are essential for understanding the process.
Science-Based Tech Selection For Bioavailability Enhancement
Explore a process based on a series of inputs including the target product profile, drug properties, extensive past project experiences, technology maps, and absorption modeling.
User Experience For Manual Injection Of 2 mL Viscous Solutions Is Enhanced By A New Prefillable Syringe
Although subcutaneous administration improves patient compliance and quality of life by enabling at-home injections, as compared to intravenous or intramuscular route, the associated anxiety, pain, discomfort, and the frequency of injections can play a significant role in patient non-adherence with chronic subcutaneous treatments. In order to address these challenges, through reducing the required frequency of subcutaneous injections and increasing injection comfort for novel biotherapeutics, drug delivery systems are needed to enable the administration of large-volume injections and/or high-viscosity drugs. We developed a pre-fillable glass syringe featuring a stacked 8 mm needle with an ultra-thin wall (UTW) cannula technology as a solution.
Challenges And Practical Solutions For Switching To Prefilled Syringes For Injectables
To achieve the benefits of moving a final product presentation from vials to prefilled syringes, it is important to understand the challenges during this solution as well as practical solutions.